(261 days)
Not Found
No
The summary describes a mechanical implant (compression plate) and its material properties and performance through bench testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No.
The device is a compression plate used for fixation of small bones and fragments, which falls under the category of orthopedic implants, used to repair or stabilize anatomical structures, not to treat a disease, injury, or condition directly in a therapeutic manner.
No
The device is described as a "Compression Plate" intended for fixation of small bone fragments, indicating a therapeutic or surgical function rather than a diagnostic one.
No
The device description clearly states it is a physical compression plate made of Nitinol, which is a hardware component. The performance studies also focus on bench testing of the physical plate and screws.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation of small fragments, osteolomics, atthrodeses, replantations, and reconstructions of small bones and small fragments." This describes a surgical implant used in vivo (within the body) for structural support and repair.
- Device Description: The description confirms it's a "Compression Plate" made of Nitinol, designed for "fixation for small bones and small fragments." This further reinforces its role as a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, tissue, or other bodily fluids, to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is implanted directly into the body.
N/A
Intended Use / Indications for Use
The dynaMXTM Compression Plate is indicated for fixation of small fragments, osteolomics, atthrodeses, replantations, and reconstructions of small bones and small fragments.
Product codes
HRS
Device Description
The dynaMX™ Compression Plate provides a means of fixation for small bones and small fragments.
- The dynaMÄ™ Compression Plate is made of biocompatible Nitinol. The bridge of . the implant is designed to exhibit superelastic properties at room temperature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones and small fragments
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of laboratory studies (bench tests) have been conducted to verify the suitability of the dynaMÄ™ Compression Plate for its intended use, establish Substantial Equivalence with the predicate devices and confirm reproducibility of the packaging.
These tests include:
Elastic Static Bending Testing
Bending Fatique Testing
Cyclic Potentiodynamic Polarization Corrosion Testing
Galvanic Corrosion Testing
Compressive Force Performance
Transformation Temperature Determination
Package Seal Strength Verification
In addition, laboratory testing has been conducted on the locking screws that are to be used with the compression plate. This testing included:
Insertion and Removal Torque
Torsional Strength
Pullout Strength
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K090047, K070447, K091609, K143023
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a simple, sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2017
MX Orthopedics, Corp. Howard Schrayer Regulatory Affairs Consultant 1050 Waltham Street Suite 510 Lexington, Massachusetts 02421
Re: K161303 Trade/Device Name: dynaMX™M Compression Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: December 22, 2016 Received: December 23, 2016
Dear Mr. Schrayer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K161303
Device Name dynaMXTM Compression Plate
Indications for Use (Describe)
The dynaMXTM Compression Plate is indicated for fixation of small fragments, osteolomics, atthrodeses, replantations, and reconstructions of small bones and small fragments.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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510(k) SUMMARY (Per 21 CFR 807.92)
General Company Information
| Name: | MӾ Orthopedics, Corp. |
|---|---|
| Contact: | Howard Schrayer |
| Regulatory Affairs Consultant | |
| Address: | 1050 Waltham St. Suite 510 |
| Lexington, MA 02421 | |
| Telephone: | (617) 207 – 8604 |
| Fax: | (617) 649 – 8484 |
| Date Prepared | January 19, 2017 |
General Device Information
| Product Name: | dynaMX™ Compression Plate |
|---|---|
| Classification: | "Plate, Fixation, Bone" |
| Product code: HRS - Class II | |
| 21 CFR 888.3030 |
Predicate Device
| Synthes (Primary Predicate) | 1.5mm Mini Fragment LCP System
[510(k) Number K090047] |
|-----------------------------|---------------------------------------------------------------|
| Newdeal | Newdeal Compression Plate
[510(k) Number K070447] |
| | Newdeal Compression Plate
[510(k) Number K091609] |
| | Wright Medical |
| BioMedical Enterprises | Nitinol Compression Plating System
[510(k) Number K143023] |
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Description
The dynaMX™ Compression Plate provides a means of fixation for small bones and small fragments.
- The dynaMÄ™ Compression Plate is made of biocompatible Nitinol. The bridge of . the implant is designed to exhibit superelastic properties at room temperature.
Indications for Use
The dynaMÄ™ Compression Plate is intended for fixation of small bones and small fragments, osteotomies, arthrodeses, replantations, and reconstructions of small bones and small fragments.
Substantial Equivalence
A series of laboratory studies (bench tests) have been conducted to verify the suitability of the dynaMÄ™ Compression Plate for its intended use, establish Substantial Equivalence with the predicate devices and confirm reproducibility of the packaging.
These tests include:
Elastic Static Bending Testing Bending Fatique Testing Cyclic Potentiodynamic Polarization Corrosion Testing Galvanic Corrosion Testing Compressive Force Performance Transformation Temperature Determination Package Seal Strength Verification
In addition, laboratory testing has been conducted on the locking screws that are to be used with the compression plate. This testing included:
Insertion and Removal Torque Torsional Strength Pullout Strength
The biocompatibility of Nitinol has been well-established.
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Technological Comparison
The dynaMX™ Compression Plate is technologically equivalent to a number of previously cleared devices. One of the cited predicated devices is fabricated from Nitinol. These metal devices are polished and chemically passivated. The size ranges (length, width and screw length) are in the same range as the dimensions of previously cleared devices intended for the same clinical applications. The devices are provided sterile and are supplied together with instruments designed to facilitate implantation. This submission supports the position that the MX Orthopedics dynaMX™ Compression Plate is substantially equivalent to previously cleared devices, including the ones listed above. A number of predicate devices list the same range of clinical uses.
Conclusions
MX Orthopedics, Corp. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the MX Orthopedics dynaMX™ Compression Plate. The materials from which the MX Orthopedics device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines.